Appclon "Henlius, AC101 Anticancer Treatment Effects Published in Two International Academic Journals"

Appclon announced on the 12th that the anticancer treatment mechanism of the gastric cancer drug 'AC101,' which was licensed to China's Henlius Biotech (Henlius), has been published in two international academic journals. AC101 was licensed to Henlius, which is currently conducting a Phase 2 clinical trial in China for HLX22, a first-line treatment for HER2-positive metastatic gastric cancer.

The company stated, "When global pharmaceutical companies were developing Herceptin biosimilars, Henlius focused on the fact that Herceptin antibody therapy did not improve overall survival in HER2-positive metastatic gastric cancer and licensed the new antibody therapy HLX22. They confirmed the combination therapy of Herceptin and HLX22 and demonstrated its superiority over existing treatments in various test models."

HLX22 explained its efficacy mechanism for HER2-positive gastric cancer in the Journal of Translational Medicine (IF: 6.1). Although HLX22 binds to a different site than Herceptin, it showed anticancer activity against gastric and breast cancers. The combination administration with Herceptin exhibited excellent HER2-positive anticancer activity. In addition to Herceptin's efficacy against cancer cell growth, HLX22 simultaneously blocks another cancer-activating HER2-EGFR (epidermal growth factor receptor) complex, leading to complete eradication of cancer cells.

The results of the Phase 2 clinical trial conducted based on HLX22's unique mechanism of action were also published in the journal Med (IF: 12.8). According to Henlius' Phase 2 clinical trial results, the HLX22 + Herceptin + chemotherapy (XELOX) combination recorded a median progression-free survival of 15.1 months when HLX22 was administered at a high concentration of 25 ppm (milligrams per kilogram). At a low concentration of 15 ppm, the value did not reach the median, showing outstanding efficacy.

An Appclon representative said, "The Phase 2 clinical trial results of HLX22 + Herceptin + chemotherapy (XELOX) showed significantly superior efficacy compared to the Keytruda combination therapy," and added, "This reconfirms the high likelihood of approval for HLX22 as a first-line treatment for HER2-positive gastric cancer."

They continued, "We have received approval for the Investigational New Drug (IND) application for the Phase 3 clinical trial in the United States for the HLX22 combination therapy as a first-line treatment for HER2-positive gastric cancer," emphasizing, "Rapid clinical progress is expected, leading to entry into the global market."